MAUDE Adverse Event Report: SURGENTEC, LLC FACETCORESYSTEM; FACETCORE LOCATOR

Lot Number SM122482

Device Problems Difficult to Remove (1528); Separation Problem (4043)

Patient Problem Insufficient Information (4580)

Event Date 10/22/2021

Event Type  malfunction  

Event Description

Guidewire was placed into facet joint, and facet locator was placed over the guidewire and advanced all the way down to the joint.The impactor was placed over the facet locator and malleted to help drive the facet locator into the proper position.The drill guide was the placed over the facet locator.When the physician tried to remove the facet locator, it would not come out, it took some time and force to remove the facet locator from its' position and when removed, one of the distal tines of the facet locator was no longer attached.Surgery was completed without further complication and facet locator issue did not add much time to overall surgery.Imaging after insertion of dowel and removal of instrumentation shows the dowel placed normally with the tine remaining in the bone superior to where the dowel was placed.

• Brand Name: FACETCORESYSTEM
• Type of Device: FACETCORE LOCATOR
• Manufacturer (Section D): SURGENTEC, LLC; 911 clint moore rd; boca raton FL 33487
• Manufacturer (Section G): SURGENTEC, LLC; 911 clint moore rd; boca raton FL 33487
• Manufacturer Contact: andrew shoup ; 911 clint moore rd; boca raton, FL 33487 ; 5619907882
• MDR Report Key: 12778285
• MDR Text Key: 281393404
• Report Number: 3012495575-2021-00003
• Device Sequence Number: 1
• Product Code: MDM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: SM122482
• Initial Date Manufacturer Received: 10/22/2021
• Initial Date FDA Received: 11/09/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1